Kit

Abstract

The kit includes a cartridge body configured to store reagent components. The cartridge includes at least one cartridge wall surrounding at least a portion of a reagent envelope configured to store a reagent component. The cartridge body includes a shelf surrounding an access port in communication with the reagent envelope. The kit includes a seal coupled to the shelf, and the seal closes the access. The seal and the cartridge cooperatively isolate the reagent envelope from an environment external to the reagent envelope.

Description

[0001] Priority Claim

[0002] This patent application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 376,260, entitled "REAGENT CARTRIDGES", filed on September 19, 2022 by Persi et al. (Attorney Docket No. 1886.018PRV), which is hereby incorporated herein by reference in its entirety. Technical Field

[0003] This document generally but not restrictively relates to reagent storage and reconstitution. Background Art

[0004] In an example, reagents are used for diagnostic tests (e.g., blood tests, genetic tests, drug discovery, etc.). For example, the reagents are stored in a container and collected from the container for chemical analysis. For example, the container includes foil and the reagents are stored therein. In another method, the reagents are stored in a glass (or plastic) container with a seal. For example, the reagents are held in a well and manually poured into a test tube for reconstitution once opened. Summary of the Invention

[0005] The inventors have recognized that, among other things, problems to be solved may include separation of reagents. In some examples, the reagents decompose when exposed to moisture. Additionally, the inventors have recognized that, among other things, problems to be solved may include foil- or plastic-wrapped reagents. For example, the foil- or plastic-wrapped reagents are cut open to obtain the reagents. In another method, the reagents are added to a container and a precise amount of diluent is added to the container by a skilled technician using a pipette to reconstitute the reagents without diluting the reagents (or leaving the reagents unreconstituted). Thus, using foil- or plastic-wrapped reagents and their reconstitution is laborious and time-consuming. Additionally, using foil- or plastic-wrapped reagents generally requires a high degree of precision to properly reconstitute the reagents.

[0006] Furthermore, the inventors have recognized that, among other things, problems to be solved may include reagents stored in glass or plastic ampoules. In a method, the ampoules need to be crushed to obtain the reagents contained therein. Thus, a reconstitution system is needed that includes mechanical features configured to safely crush the ampoules and then reconstitute the reagents contained therein.

[0007] The present subject matter can help provide a solution to the problem, for example, by providing a solution in a kit. The kit includes reagent components isolated within a reagent envelope. For example, the reagent envelope (e.g., the box wall, the seal, etc.) isolates the reagent components from the environment through the envelope. In another example, the reagent components are lyophilized (e.g., dried, freeze-dried, baked, etc.). The box includes one or more features, such as an access port, a seal, etc., and the one or more features isolate the reagent components and provide an access port for reconstituting the reagent components (e.g., with a diluent, etc.) and discharging the reconstituted reagent from the kit. The kit examples described herein provide easy access to the reagent.

[0008] In addition, the kit provides a well for reconstituting the reagent components. A diluent is received within the well to facilitate reconstitution, and the reconstituted reagent is extracted from the well. As discussed herein, the extraction is performed in one or more arrangements. In some examples, the kit facilitates flushing of the diluent through the well to reconstitute the reagent components. In another example, the reconstituted reagent is delivered to a location for testing (e.g., a reservoir including a sample). For example, the box includes a box wall having a tapered profile, and in one of these examples, the tapered profile is vertical (including a vertical orientation angled relative to true vertical, such as 0 degrees to 15 degrees, etc.). The tapered profile guides the reagent components (or the reconstituted reagent) for collection. For example, in an example, the tapered guide and collects the reconstituted reagent in a funnel-shaped well, and a pipette is used to discharge all of the reconstituted reagent with the assistance provided by the tapered profile.

[0009] In other examples, the tapered profile is horizontal. The box having the tapered profile receives a diluent to reconstitute the reagent, and the diluent flow (and optionally gravity or the force of the flow cooperating with the taper) transports the reconstituted reagent downstream from the box to a test assembly. Thus, in one example, the box serves as a conduit, tube, etc. that contains the reagent, receives the diluent flow, and flushes the reconstituted reagent downstream.

[0010] In another example, the kit is coupled to a reconstitution assembly in a vertical orientation (including a vertical orientation angled relative to true vertical, such as 0 degrees to 15 degrees, etc.). The kit contains reagent components, and the reagent components are reconstituted in a well of the kit. For example, a first piercing element pierces a first seal and provides access to the reagent envelope through a first access port. The first piercing element (or another instrument) introduces a diluent into the kit through the first access port. The diluent is within the kit, for example, reconstituting the reagent components in a well of the reagent envelope. A second piercing element pierces a second seal and provides access to the reagent envelope through a second access port. The reconstituted reagent is discharged using the second piercing element or another instrument through the second access port. Thus, in this example, the first access port allows reconstitution of the reagent components, and the second access port allows discharge of the reconstituted reagent from the reagent container.

[0011] This summary is intended to provide an overview of the subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive description of the invention. The detailed description is included to provide additional information regarding the present patent application. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] In the drawings which are not necessarily to scale, like reference numerals may describe similar components in different views. Similar numerals with different letter suffixes may represent different instances of similar components. The drawings generally illustrate, by way of example and not limitation, the various embodiments discussed in this document.

[0013] Figure 1A A perspective exploded view of an example of the kit is shown.

[0014] Figure 1B Shows Figure 1A An exploded cross-sectional view of the kit of

[0015] Figure 1C Shows Figure 1A Another cross-sectional view of the kit of

[0016] Figure 2A A perspective exploded view of another example of the kit is shown.

[0017] Figure 2B Shows Figure 2A An exploded cross-sectional view of the kit of

[0018] Figure 2C Shows Figure 2A Another cross-sectional view of the kit of

[0019] Figure 2D Shows Figure 2A Another cross-sectional view of the kit of

[0020] Figure 2E Shows Figure 2A Another cross-sectional view of the kit of

[0021] Figure 3A A perspective exploded view of another example of the kit is shown.

[0022] Figure 3B Shows Figure 3A An exploded cross-sectional view of the kit of

[0023] Figure 3C Shows Figure 3A Another cross-sectional view of the kit of

[0024] Figure 3D Shows Figure 3A Another cross-sectional view of the kit of

[0025] Figure 4A A perspective exploded view showing another example of the kit.

[0026] Figure 4B Shows Figure 4A An exploded cross-sectional view of the kit of

[0027] Figure 5A A perspective exploded view showing another example of the kit.

[0028] Figure 5B Shows Figure 5A An exploded cross-sectional view of the kit of

[0029] Figure 6 An exploded cross-sectional view showing yet another example of the kit.

[0030] Figure 7 Shows an example of a method of using the kit. Detailed Description

[0031] Figure 1A An exploded view showing example kit 100. Kit 100 has a case 102, and the case 102 includes a case wall 104. The case wall 104 optionally includes multiple layers. For example, the case wall 104 includes a plastic layer, an intermediate air cavity between the plastic layers, a desiccant layer between the plastic layers, etc.

[0032] The case wall 104 surrounds Figure 1A At least a portion of the reagent envelope 106 shown in dashed lines in. The reagent envelope 106 contains reagent components 108, such as lyophilized reagents. The reagent envelope 106 isolates the reagent components 108 from the environment outside the reagent envelope 106, which might otherwise contaminate or dilute the reagent components. In the example, the reagent components 108 are in dry form or liquid form. For example, the reagent components 108 are lyophilized (e.g., dried, freeze-dried, oven-dried, etc.). The lyophilized reagent components 108 are reconstituted, for example, by introducing a diluent (e.g., deionized water, etc.) into the reagent envelope 106, and the diluent rehydrates the reagent and provides a reagent solution.

[0033] In the example, kit 100 includes one or more seals 110 ( Figure 1A110A and 110B in). In another example, the seal 110 includes one or more of a hydrophobic and impermeable (e.g., having limited permeability) foil, polymer film, combination of foil and polymer film, laminate of foil and polymer film, etc. For example, the kit includes a first seal 110A and a second seal 110B. The seal 110 is coupled to the cartridge body 102. The seal 110 cooperates with the cartridge body 102 to isolate the reagent envelope 106 from exposure to the environment. For example, the seal 110 and the cartridge body inhibit the moisture transmission rate between the environment and the reagent envelope. In another example, the seal 110 minimizes the entry of air, moisture, etc. into the reagent envelope 106 through the access openings enclosed by the seal.

[0034] As described herein, in various examples, one or more seals 110 are pierced for reconstitution and the reconstituted reagent is discharged from the reagent envelope 106. In one example, the seal 110B closing the first access opening of the reagent envelope is penetrated to introduce diluent into the reagent envelope 106 for reconstitution. In another example, the reconstituted reagent is discharged from the reagent envelope 106 through the access opening opened by the penetrated seal 110B. In yet another example, the seal 110A is pierced to discharge (e.g., remove, extract, etc.) the reconstituted reagent from the reagent envelope 106. As discussed herein, the discharge of the reagent from the cartridge having multiple access openings is in the manner of a tube or pipe located within a larger system, which allows the reagent solution to flow through the cartridge. Optionally, the taper, orientation, both, etc. facilitate the discharge of the reagent solution.

[0035] Figure 1B shows Figure 1A a cross-sectional exploded view of the kit 100. Figure 1B shows that the cartridge body 102 includes one or more cartridge shelves 112 (e.g., bosses, flanges, etc.). For example, the first end portion 114 of the cartridge body 102 has a first cartridge shelf 112A. The second end portion 116 of the cartridge body 102 has a second cartridge shelf 112B. In the example, the cartridge shelf 112 extends between the inner wall surface 118 and the outer wall surface 120 of the cartridge body 102. The cartridge shelf 112 provides an expansion surface for coupling with the seal 110. For example, the cartridge shelf 112 provides a surface for coupling with the corresponding seal 110, rather than coupling with the seal 110 along the edge near the inner wall surface 118.

[0036] As shown in this embodiment, the first seal 110A is coupled to the first cartridge shelf 112A and closes the first end portion 114. The second seal 110B is coupled to the second cartridge shelf 112B and closes the second end 116. The seal 110 and the cartridge body 102 cooperate to isolate the reagent envelope 106 from the environment.

[0037] Kit 100 includes one or more access ports 122. As discussed herein, access ports 122 facilitate reconstitution of reagents and discharge of reconstituted reagents from reagent envelope 106. In an example, first cassette shelf 112A surrounds first access port 122A. In another example, second cassette shelf 112B surrounds second access port 122B. Access ports 122 are in communication with reagent envelope 106.

[0038] Figure 1C Another cross-sectional view of the Figure 1A kit in an assembled configuration is shown. First seal 110A is coupled to cartridge body 102 along first shelf 112A (shown in Figure 1B ). Second seal 110B is coupled to cartridge body 102 along second shelf 112B (shown in Figure 1B ). As previously discussed, shelves 112A, 112B provide an expanded surface for coupling with respective seals 110A, 110B. Seals 110A, 110B and their secure coupling along the expanded surface enhance impermeability at access ports 122A, 122B (see Figure 1B ). Thereby, seals 110 and cartridge body 102 cooperate to isolate reagent envelope 106 (shown in dashed lines in Figure 1C ) from the environment external to reagent envelope 106.

[0039] In one example, cartridge body 102 is configured as a split portion of an extruded linear tube. Cartridge body 102 is optionally cleaned and coupled with one or more components including a sheath that enhances impermeability of the cartridge material, a desiccant layer, etc. In another example, cartridge body 102 is injection molded, pultruded, etc.

[0040] Figure 2A A perspective exploded view of another example of kit 200 is shown. In the example, kit 200 includes cartridge body 202, cartridge wall 204, reagent envelope 206 (shown in dashed lines in Figure 2A ), reagent components 208, and seal 210. Kit 200 optionally includes one or more flanges 224. In this example, one or more shelves 212 include flanges 224 that extend from the remainder of cartridge body 102. Flanges 224 provide an enhanced surface area for coupling of the cartridge body with seal 110. In another example, flanges 224 function as indexing features 226 for accurately loading kit 200 into a reconstitution assembly.

[0041] In the example, flanges 224A, 224B are shelves for coupling the seal 210 to the cartridge 202. The recessed area 225 between flange 224A and flange 224B can be surrounded by another wall to provide a layered wall including an outer wall, air, rare gas or vacuum chamber, and an inner wall (e.g., cartridge wall 204, etc.). In another example, the recessed area 225 is loaded with a desiccant.

[0042] Figure 2B A cross-sectional exploded view of Figure 2A kit 100 is shown. Flange 224 includes a first flange 224A at a first end portion 114 of the cartridge 102. Flange 224 includes a second flange 224B at a second end portion 216 of the cartridge 202. In the example, flange 224 surrounds the access port 222. In another example, flange 224 extends away from the cartridge wall 204. In yet another example, flange 224 enhances the coupling between the seal 210 and the cartridge 202.

[0043] Figure 2C A cross-sectional view of Figure 2A another kit 200 is shown. The first seal 210A is coupled to the first flange 224A. For example, the first seal 210A cooperates with the first flange 224A to enclose (e.g., seal, isolate, surround, confine, restrict, etc.) the first end portion 214 of the kit 200. The second seal 210B is coupled to the second flange 224B. For example, the second seal 110B cooperates with the second flange 224B to enclose the second end portion 116 of the kit 100. Thus, the reagent envelope 206 (shown in Figure 2C dashed lines) is isolated from the environment external to the reagent envelope 206. For example, the seal 210 cooperates with the flange 224 and the remainder of the cartridge 202 to isolate the reagent envelope 206 (and the reagent components 208 contained therein) from the environment external to the reagent envelope 206.

[0044] Figure 2D A cross-sectional view of Figure 2A kit 200 in an example reconstitution configuration and extraction configuration is shown. Kit 200 is contained within the reconstitution assembly 226. For example, kit 100 has a cartridge profile. The cartridge profile is readily received within the complementary socket 228 of the reconstitution assembly 226. The reconstitution assembly 226 facilitates the introduction of the diluent 230 into the reagent envelope 206, reconstitution within the envelope 206, and the discharge of the reconstituted reagent from the reagent envelope 206 in a controlled environment to allow for automated testing of the sample.

[0045] The reconstitution assembly 226 facilitates the reconstitution of the reagent component 208 located in the reagent envelope 206. For example, the reconstitution assembly 226 includes a first piercing element 232 that pierces the first seal 210A. In an example, the first piercing element 232 optionally introduces a diluent 230 into the reagent envelope 206. The diluent 230 mixes with the reagent component 208 and reconstitutes the reagent within the reagent envelope 206.

[0046] Figure 2D It is also shown that the reconstitution assembly 226 includes a second piercing element 234. The second piercing element 234 (e.g., a needle, syringe, etc.) pierces the second seal 210B. In an example, the second piercing element 234 discharges the reagent that has been previously reconstituted in the reagent envelope 206. For example, the second piercing element 234 applies suction and works with gravity, etc. to discharge the reagent from the reagent envelope 206. Thus, the reconstitution assembly 226 facilitates the introduction of the diluent 230 into the reagent envelope 206, the reconstitution within the envelope 206, and the discharge of the reconstituted reagent from the reagent envelope 106.

[0047] Figure 2E Is shown Figure 2A Another cross-sectional view of the kit 200, where the reagent is reconstituted into a liquid form. The reagent component 208 (as Figure 2D shown) has been reconstituted with the diluent 230 (as Figure 2D shown). In this exemplary embodiment, the second piercing element 234 of the reconstitution assembly 226 then penetrates the second seal 210B to discharge the reconstituted reagent 236 from the reagent envelope 206. In another example, one or more of the seals 210 are unsealed (e.g., pierced, punctured, removed, opened, peeled, separated, torn, etc.) to allow the reconstituted reagent 212 to flow out of the kit 100.

[0048] Referring again to Figures 2A to 2E , in an example, the diluent 230 is introduced into the reagent envelope 206 through the first access port 222A. The reagent component 208 is reconstituted in the reagent envelope 206. The reconstituted reagent 236 is discharged from the reagent envelope through the second access port 222B. Thus, the reconstitution assembly 226 allows for staged reconstitution and then the discharge of the reconstituted reagent 236 from the reconstitution assembly 226. Thus, in one example, the cartridge 200 serves as a conduit, tube, etc. that contains the reagent, receives a flow of diluent, and flushes the reconstituted reagent downstream. In an example, the kits 400, 500, and 600 are reconstituted in a manner similar to the kit 200.

[0049] Figure 3A And Figure 3B (respectively) show an exploded perspective view and an exploded cross-sectional view of another example of the kit 300. In an example, the kit 300 includes a cartridge body 302, a cartridge wall 304, a reagent envelope 306 (inFigure 3A and Figure 3B shown in dashed lines), reagent component 308, seal 310A, and flange 300A. In the example, cartridge wall 304 has a tapered profile. For example, the second end portion 316 of cartridge 302 tapers away from the first end portion 314 of cartridge 302. In another example, the second end portion 316 of cartridge 302 is sealed. Thus, in some examples, cartridge wall 304 provides aperture 338. Aperture 338 is a tapered feature (e.g., funnel, guide, etc.) of cartridge wall 304 that correspondingly tapers reagent envelope 306. For example, aperture 338 retains reagent 308 in a specified location and guides reconstitution and retention of the reconstituted reagent to a specified location of reagent envelope 306. Guiding the reconstituted reagent to a specified location (e.g., tapered or funnel-shaped aperture 338) facilitates collection of reconstituted reagent 336 (as Figure 3D shown) within reagent envelope 306.

[0050] Figure 3C shows Figure 3A Another cross-sectional view of kit 300. Kit 300 is received within reconstitution assembly 326. As described herein, reconstitution assembly 326 facilitates reconstitution of reagent component 308. For example, first piercing element 332 optionally pierces seal 310A to introduce diluent 330 into reagent envelope 306. Thus, diluent 330 is mixed with reagent component 308 to provide reconstituted reagent, such as Figure 3D reconstituted reagent 336 as shown therein.

[0051] Figure 3D shows Figure 3A Another cross-sectional view of kit 300. First piercing element 332 is optionally used to expel reconstituted reagent 336 from reagent envelope 306. For example, first piercing element 332 extends into aperture 338 of kit 300. Thus, first piercing element 332 collects reconstituted reagent 212 from aperture 338.

[0052] Figure 4A and Figure 4B (respectively) show an exploded perspective view and an exploded cross-sectional view of another example of kit 400. In the example, kit 400 includes cartridge 402, cartridge wall 404, reagent envelope 406 (shown in dashed lines in Figure 4A and Figure 4B ), reagent component 408, seal 410A, and flange 424A (e.g., a shelf of the kit in this example). In another example, kit 400 includes aperture 438 that facilitates collection of reagent component 408 into reagent envelope 406.

[0053] In an example, the second end portion 11 of the cartridge 104 is sealed. In this example, the second end portion 116 of the cartridge 102 optionally has a break location 440. For example, the break location 440 has a different thickness (e.g., thinner, less thick, etc.) relative to the cartridge wall 404. In another example, the break locus 440 is more frangible than the remainder of the cartridge 404. The break location 440 of the cartridge 402 is opened by a break (e.g., piercing, rupturing, cracking, etc.) to provide an access port for the reagent component 408. For example, the break locus 440 breaks to expel one or more of the reagent component 408 or the reconstituted reagent from the reagent envelope 406. In another example, a reconstitution assembly (e.g., Figure 3C the reconstitution assembly 326 shown in

[0054] breaks the break location 400.

[0055] Figure 5A and Figure 5B (respectively) show a perspective view and a cross-sectional view of another example of the kit 500. In an example, the kit 500 includes a cartridge 502, a cartridge wall 504, a reagent envelope 506 (shown in dashed lines in Figure 5A and Figure 5B ), a reagent component 508, a seal 510, an access port 522, and a flange 524. A first seal 510A seals a first access port 522A. A second seal 510B seals a second access port 522B. Thus, the reagent envelope 506 is isolated from the environment external to the reagent envelope 506.

[0056] In an example, the cartridge wall 504 has a tapered profile. For example, the second end portion 516 of the cartridge 502 tapers away from the first end portion 514 of the cartridge 502. For example, the tapered profile guides one or more of the reagent component or the reconstituted reagent toward the access port, such as the second access port 522B. In another example, the cartridge wall 504 having a tapered profile tapers toward the second access port 522B. The tapered profile collects and guides the reagent component 508 within the reagent envelope 506. For example, the tapered profile collects and guides the reagent component 508 (or the reconstituted reagent) to be discharged by an instrument through the second access port 522B.

[0057] The tapered profile of the cartridge wall 504 is optionally different from Figure 5A 、 Figure 5BThe profile shown. For example, the portion of the cartridge wall having a tapered profile is optionally less than Figure 5A , Figure 5B the portion shown in. In other words, the tapered portion of the cartridge wall is optionally shorter than Figure 5A , Figure 5B the portion shown in. In another example, the kit 500 is provided in a vertical configuration (instead of the Figure 5B horizontal configuration shown in).

[0058] In another example, the kit 500 includes a guiding member 526 for accurately loading the kit 100 into the reconstitution assembly. For example, the guiding member 526 facilitates a one-way coupling of the kit 500 with the reconstitution assembly. For example, the guiding member 526 includes a keyway 542 that receives a component of the reconstitution assembly and facilitates accurately loading the kit 500 into the reconstitution assembly. In yet another example, the flange 534B serves as a key for accurately loading the kit 500 into the reconstitution assembly. In still another example, the guiding member 526 includes one or more of a slot, a groove, a dent, a notch, etc.

[0059] In some examples, the kit 100 is coupled to the reconstitution assembly (e.g., Figure 2D the reconstitution assembly 204 shown in) in a horizontal configuration (including a horizontal orientation angled relative to true horizontal, such as 0 degrees to 15 degrees, etc.). Figure 5B A kit in a horizontal configuration is shown. In another example, the kit 100 is coupled to the reconstitution assembly in a vertical configuration (including a vertical orientation angled relative to true vertical, such as 0 degrees to 15 degrees, etc.). Figure 2E A kit in a vertical configuration is shown.

[0060] Figure 6 A cross-sectional view of yet another example of the kit 600 is shown. In the example, the kit 600 includes a cartridge body 602, a cartridge wall 604, a reagent envelope 606 (shown in dashed lines in Figure 6 ), a reagent component 608, seals 610A and 610B, and flanges 624A and 624B. Figure 6 The cartridge wall 604 having a tapered profile is shown. For example, the tapered profile widens towards the first access port 622A. In the example, the tapered profile minimizes the retention of the reconstituted reagent within the reagent envelope 106.

[0061] Figure 7An example of method 700 using a kit (e.g., one or more of kits 100, 200, 300, 400, 500, 600) is shown. In describing method 700, reference is made to one or more components, features, functions, and operations previously described herein. Where convenient, reference numerals are used to refer to components, features, operations, etc. The reference numerals provided are exemplary and not exclusive. For example, the components, features, functions, operations, etc. described in method 700 include, but are not limited to, the correspondingly numbered elements provided herein and other corresponding elements (both numbered and unnumbered) described herein, as well as their equivalents.

[0062] At 702, method 700 includes: unsealing a first end portion 114 of kit 100 to access a reagent envelope 106 containing reagent components 108. Method 700 includes: reconstituting the reagent components at 704. For example, at 706, the method includes: introducing a diluent through the first end portion 114 and a first access port 122A in communication with the reagent envelope 106. In another example, method 700 includes: reconstituting reagent components 108 with diluent 230 in reagent envelope 106 at 708. At 710, method 700 includes: discharging the reconstituted reagent through a second access port 122B in communication with the reagent envelope 106.

[0063] Several options for method 700 are as follows. In an example, discharging the reconstituted reagent from the reagent envelope includes: unsealing a second end portion 116 of kit 100 to access the reagent envelope 106, wherein the second end portion 116 of kit 100 has a second access port. In this example, the reconstituted reagent 236 is discharged through the second access port 122B. In another example, unsealing the second end portion 116 of kit 100 includes: breaking kit 100 at a break location 440. In yet another example, unsealing the first end portion 114 of the kit includes: piercing a seal 110A. In still another example, unsealing the first end portion 114 of kit 100 includes: removing a seal 110A from kit 100. In additional examples, method 700 includes: passing an instrument (e.g., a pipette, a needle, a piercing element, etc.) through the access port 122A at the first end portion 114 of kit 100.

[0064] Various notes and aspects

[0065] Example 1 is a kit, comprising: a box body configured to store reagent components, the box body including: at least one box wall surrounding at least a portion of a reagent envelope configured to store the reagent components; a shelf surrounding an access opening in communication with the reagent envelope; and a seal coupled to the shelf and closing the access opening, wherein the seal and the box body cooperate to isolate the reagent envelope from the environment external to the reagent envelope.

[0066] In Example 2, the subject matter according to Example 1 optionally includes, wherein: the shelf includes a first shelf and a second shelf; the access opening includes a first access opening and a second access opening; the first shelf surrounds the first access opening; the second shelf surrounds the second access opening; the seal includes a first seal and a second seal; the first seal is coupled to the first shelf and closes the first access opening; and the second seal is coupled to the second shelf and closes the second access opening.

[0067] In Example 3, the subject matter according to any one or more of Examples 1 to 2 optionally includes, wherein the box wall has a tapered profile.

[0068] In Example 4, the subject matter according to Example 3 optionally includes, wherein the tapered profile narrows towards the access opening.

[0069] In Example 5, the subject matter according to any one or more of Examples 3 to 4 optionally includes, wherein the tapered profile widens towards the access opening.

[0070] In Example 6, the subject matter according to any one or more of Examples 1 to 5 optionally includes, wherein the box body has a guiding component configured to orient the kit relative to a reconstitution assembly.

[0071] In Example 7, the subject matter according to Example 6 optionally includes, wherein the guiding component includes a keyway provided on the box body.

[0072] In Example 8, the subject matter according to any one or more of Examples 6 to 7 optionally includes, wherein the guiding component includes a key provided on the box body.

[0073] In Example 9, the subject matter according to any one or more of Examples 6 to 8 optionally includes, wherein the shelf includes a flange extending away from the box wall, and the guiding component is included in the flange.

[0074] In Example 10, the subject matter according to any one or more of Examples 1 to 9 optionally includes, wherein the cartridge includes a break location, and the break location is configured to preferably break near an end of the cartridge.

[0075] In Example 11, the subject matter according to Example 10 optionally includes, wherein the cartridge wall has a tapered profile, and the tapered profile guides the reconstituted reagent towards the break location.

[0076] In Example 12, the subject matter according to any one or more of Examples 1 to 11 optionally includes, wherein the shelf includes a flange extending away from the cartridge wall.

[0077] In Example 13, the subject matter according to Example 12 optionally includes, wherein the shelf extends between an inner wall surface and an outer wall surface.

[0078] In Example 14, the subject matter according to any one or more of Examples 1 to 13 optionally includes, wherein the access port is configured to receive a piercing element to provide diluent to the reagent component.

[0079] In Example 15, the subject matter according to Example 14 optionally includes, wherein: the shelf includes a first shelf and a second shelf; the access port includes a first access port and a second access port; the first shelf surrounds the first access port; the second shelf surrounds the second access port; the piercing element is a first piercing element, and the first access port is configured to receive the first piercing element; and the second access port is configured to receive a second piercing element to discharge the reconstituted reagent from the reagent envelope, the reconstituted reagent including the diluent and the reagent component.

[0080] In Example 16, the subject matter according to any one or more of Examples 14 to 15 optionally includes, wherein the piercing element is configured to discharge the reconstituted reagent from the reagent envelope, the reconstituted reagent including diluent and the reagent component.

[0081] In Example 17, the subject matter according to any one or more of Examples 1 to 16 optionally includes, wherein the access port is configured to receive a piercing element to discharge the reconstituted reagent, the reconstituted reagent including diluent and the reagent component.

[0082] In Example 18, the subject matter according to Example 17 optionally includes, wherein the cartridge wall has a tapered profile, and the tapered profile guides the reconstituted reagent towards the access port.

[0083] In Example 19, the subject matter according to any one or more of Examples 1 to 18 optionally includes, wherein the cartridge includes one or more of polypropylene, polystyrene, acrylic, polyolefin, or the registered trademark Topas.

[0084] Example 20 is a kit, including: a cartridge configured to store reagent components, the cartridge including: a first end portion; a second end portion; at least one cartridge wall surrounding at least a portion of a reagent envelope configured to store the reagent components; and a first shelf surrounding an access opening located at the first end of the cartridge, the first access opening communicating with the reagent envelope; a first seal coupled to the first shelf and closing the first access opening and the first end portion of the cartridge, wherein the seal and the cartridge cooperate to isolate the reagent envelope from the environment external to the reagent envelope; and wherein the second end portion of the cartridge is selectively openable.

[0085] In Example 21, the subject matter according to Example 20 optionally includes, wherein the second end of the cartridge has a break location to facilitate selective opening of the kit.

[0086] In Example 22, the subject matter according to any one or more of Examples 20 to 21 optionally includes, wherein the second end portion of the cartridge has a second seal closing the second end of the cartridge, and the seal is pierceable or removable to facilitate selective opening of the kit.

[0087] In Example 23, the subject matter according to Example 22 optionally includes, wherein the second end of the cartridge has a second access opening surrounded by a second shelf, and the second seal is coupled to the second shelf to close the second access opening.

[0088] In Example 24, the subject matter according to any one or more of Examples 20 to 23 optionally includes, wherein the access opening is configured to receive a piercing element to discharge the reconstituted reagent, the reconstituted reagent including a diluent and the reagent components.

[0089] In Example 25, the subject matter according to any one or more of Examples 20 to 24 optionally includes, wherein the kit has a reconstitution configuration and an extraction configuration: in the reconstitution configuration, the access opening is open, and the reagent envelope and the reagent components therein are configured to receive a diluent through the access opening; and in the extraction configuration, the second end portion is open, and the reagent reconstituted in the reconstitution configuration is delivered through the opened second end portion.

[0090] In Example 26, the subject matter according to Example 25 optionally includes, wherein the reagent reconstituted in the reconstitution configuration is delivered away from the first end portion and through the second end portion.

[0091] Example 27 is a method of using a kit, comprising: unsealing a first end portion of the kit to access a reagent envelope that contains reagent components; reconstituting the reagent components, including: introducing a diluent through the first end and a first access port in communication with the reagent envelope; and reconstituting the reagent components with the diluent in the reagent envelope; and discharging the reconstituted reagent through a second access port in communication with the reagent envelope.

[0092] In Example 28, the subject matter according to Example 27 optionally includes, wherein discharging the reconstituted reagent from the reagent envelope comprises: unsealing a second end portion of the kit to access the reagent envelope, wherein the second end portion of the kit has the second access port; discharging the reconstituted reagent through the second access port.

[0093] In Example 29, the subject matter according to any one or more of Examples 27 to 28 optionally includes: unsealing a second end portion of the kit to access the reagent envelope.

[0094] In Example 30, the subject matter according to Example 29 optionally includes, wherein unsealing the second end portion of the kit comprises: breaking the kit at a break location.

[0095] In Example 31, the subject matter according to any one or more of Examples 29 to 30 optionally includes, wherein unsealing the first end portion of the kit comprises: piercing a seal.

[0096] In Example 32, the subject matter according to any one or more of Examples 27 to 31 optionally includes, wherein unsealing the first end portion of the kit comprises: removing a seal from the kit.

[0097] In Example 33, the subject matter according to any one or more of Examples 27 to 32 optionally includes: passing an instrument through an access port at the first end portion of the kit.

[0098] Each of these non-limiting examples may exist independently, or may be combined with one or more other examples in various arrangements or combinations.

[0099] The above description includes references to the accompanying drawings which form a part of the detailed description. The drawings illustrate, by way of example, specific embodiments in which the invention may be practiced. Such embodiments are also referred to herein as "examples". Such examples may include elements other than those shown or described. However, the inventors also contemplate examples in which only those elements shown or described are provided. In addition, the inventors also contemplate examples using any combination or arrangement of those elements (or one or more aspects of those elements) shown or described relative to a particular example (or one or more aspects of a particular example) or relative to other examples (or one or more aspects of other examples) shown or described herein.

[0100] If there is any inconsistency in the usage between this document and any document incorporated by reference, the usage in this document shall prevail.

[0101] In this document, the terms "a" or "an" are used, as is common in patent documents, to include one or more than one, regardless of any other instances or uses of "at least one" or "one or more". In this document, unless otherwise specified, the term "or" is used to refer to a non-exclusive or, such that "A or B" includes "A but not B", "B but not A", and "A and B". In this document, the terms "including" and "in which" are used as the plain English equivalents of the respective terms "comprising" and "wherein". Further, in the appended claims, the terms "including" and "comprising" are open-ended, i.e., a system, apparatus, article, composition, formulation, or process that includes elements other than those listed after such a term in the claims is still considered to fall within the scope of that claim. Further, in the appended claims, the terms "first", "second", "third", etc. are used only as labels and are not intended to impose numerical requirements on their objects.

[0102] Unless the context otherwise requires, geometric terms such as "parallel", "perpendicular", "circular", or "square" are not intended to require absolute mathematical precision. Instead, such geometric terms allow for variations due to manufacturing or equivalent functionality. For example, if an element is described as "circular" or "substantially circular", a component that is not precisely circular (e.g., one that is slightly oval or polygonal with many sides) is still covered by the description.

[0103] The method examples described herein can be at least partially machine or computer-implemented. Some examples can include a computer-readable medium or machine-readable medium encoded with instructions that are operable to configure an electronic device to perform the methods described in the examples above. Implementations of such methods can include code, such as microcode, assembly language code, higher-level language code, etc. Such code can include computer-readable instructions for performing various methods. The code can form part of a computer program product. Additionally, in an example, during execution or at other times, the code can be tangibly stored on one or more volatile, non-transitory, or non-volatile tangible computer-readable media. Examples of such tangible computer-readable media can include, but are not limited to, hard disks, removable disks, removable optical disks (e.g., compact disks and digital video disks), magnetic cassettes, memory cards or sticks, random access memory (RAM), read-only memory (ROM), etc.

[0104] The above description is intended to be illustrative, not restrictive. For example, the above examples (or one or more aspects thereof) can be used in combination with each other. Other implementations can be used, for example, by one of ordinary skill in the art upon reviewing the above description. The abstract is provided to comply with 37 C.F.R. § 1.72(b) so that readers can quickly ascertain the essence of the technical disclosure. With this understanding, the abstract will not be used to interpret or limit the scope or meaning of the claims. Additionally, in the above detailed description, various features can be grouped together to simplify the disclosure. This should not be construed as intending that the disclosed features not claimed are necessary for any claim. Rather, the inventive subject matter can lie in less than all of the features of a particular disclosed implementation. Thus, the following claims are hereby incorporated into the detailed description as examples or implementations, where each claim stands on its own as a separate implementation, and it is expected that such implementations can be combined with each other in various combinations or permutations. The scope of the present invention should be determined with reference to the appended claims and the full scope of the equivalents to which those claims are entitled.

Claims

1. A kit, comprising: a cassette configured to store reagent components, the cassette including: at least one cassette wall surrounding at least a portion of a reagent envelope configured for storage of the reagent components; and a shelf surrounding an access opening in communication with the reagent envelope; and a seal coupled to the shelf and closing the access opening, wherein the seal and the cassette cooperate to isolate the reagent envelope from the environment external to the reagent envelope.

2. The kit according to claim 1, wherein: the shelf includes a first shelf and a second shelf; the access opening includes a first access opening and a second access opening; the first shelf surrounds the first access opening; the second shelf surrounds the second access opening; the seal includes a first seal and a second seal; the first seal is coupled to the first shelf and closes the first access opening; and the second seal is coupled to the second shelf and closes the second access opening.

3. The kit according to claim 1, wherein, the cassette wall has a tapered profile.

4. The kit according to claim 3, wherein, the tapered profile narrows towards the access opening.

5. The kit according to claim 3, wherein, the tapered profile widens towards the access opening.

6. The kit according to claim 1, wherein, the cassette has a guiding member configured to orient the kit relative to a reconstitution assembly.

7. The kit according to claim 6, wherein, the guiding member includes a keyway provided on the cassette.

8. The kit according to claim 6, wherein, the guiding member includes a key provided on the cassette.

9. The kit according to claim 6, wherein, the shelf includes a flange extending away from the cassette wall and the guiding member is included in the flange.

10. The kit according to claim 1, wherein, the cassette includes a break location configured to preferentially break near an end of the cassette.

11. The kit according to claim 10, wherein, the cassette wall has a tapered profile and the tapered profile guides reconstituted reagent towards the break location.

12. The kit according to claim 1, wherein, the shelf includes a flange extending away from the cassette wall.

13. The kit according to claim 12, wherein, the shelf extends between an inner wall surface and an outer wall surface.

14. The kit according to claim 1, wherein, the access opening is configured to receive a piercing element to provide diluent to the reagent components.

15. The kit according to claim 14, wherein: the shelf includes a first shelf and a second shelf; the access opening includes a first access opening and a second access opening; the first shelf surrounds the first access opening; the second shelf surrounds the second access opening; The piercing element is a first piercing element, and the first inlet / outlet is configured to receive the first piercing element; and the second inlet / outlet is configured to receive a second piercing element to discharge the reconstituted reagent from the reagent envelope, the reconstituted reagent including the diluent and the reagent component.

16. The kit according to claim 14, wherein, the piercing element is configured to discharge the reconstituted reagent from the reagent envelope, the reconstituted reagent including a diluent and the reagent component.

17. The kit according to claim 1, wherein, the inlet / outlet is configured to receive a piercing element to discharge the reconstituted reagent, the reconstituted reagent including a diluent and the reagent component.

18. The kit according to claim 17, wherein, the box wall has a tapered profile, and the tapered profile guides the reconstituted reagent towards the inlet / outlet.

19. The kit according to claim 1, wherein, the box body comprises one or more of polypropylene, polystyrene, acrylic, polyolefin or the registered trademark Topas.

20. A kit, comprising: a box body configured to store reagent components, the box body comprising: a first end portion; a second end portion; at least one box wall surrounding at least a portion of a reagent envelope configured for storage of the reagent components; and a first shelf surrounding an inlet / outlet at the first end of the box body, the first inlet / outlet communicating with the reagent envelope; a first seal coupled to the first shelf and closing the first inlet / outlet and the first end portion of the box body, wherein the seal and the box body cooperate to isolate the reagent envelope from the environment external to the reagent envelope; and wherein the second end portion of the box body is selectively openable.

21. The kit according to claim 20, wherein, the second end portion of the box body has a break position to facilitate selective opening of the kit.

22. The kit according to claim 20, wherein, the second end portion of the box body has a second seal closing the second end portion of the box body, and the seal is pierceable or removable to facilitate selective opening of the kit.

23. The kit according to claim 22, wherein, the second end of the box body has a second inlet / outlet surrounded by a second shelf, and the second seal is coupled to the second shelf to close the second inlet / outlet.

24. The kit according to claim 20, wherein, the inlet / outlet is configured to receive a piercing element to discharge the reconstituted reagent, the reconstituted reagent including a diluent and the reagent component.

25. The kit according to claim 20, wherein, the kit has a reconstitution configuration and an extraction configuration: In the reconstitution configuration, the inlet / outlet is opened, and the reagent cassette and the reagent components in the reagent cassette are configured to receive diluent through the inlet / outlet; and In the extraction configuration, the second end portion is opened, and the reagent reconstituted in the reconstitution configuration is delivered through the opened second end portion.

26. The kit according to claim 25, wherein, The reagent reconstituted in the reconstitution configuration is delivered away from the first end portion and through the second end portion.

27. A method of using a kit, comprising: unsealing the first end portion of the kit to access the reagent cassette containing reagent components; reconstituting the reagent components, including: introducing diluent through the first end portion and a first inlet / outlet in communication with the reagent cassette; and using the diluent in the reagent cassette to reconstitute the reagent components; and discharging the reconstituted reagent through a second inlet / outlet in communication with the reagent cassette.

28. The method according to claim 27, wherein, Discharging the reconstituted reagent from the reagent cassette includes: unsealing the second end portion of the kit to access the reagent cassette, wherein the second end portion of the kit has the second inlet / outlet; discharging the reconstituted reagent through the second inlet / outlet.

29. The method according to claim 27, further comprising: unsealing the second end portion of the kit to access the reagent cassette.

30. The method according to claim 29, wherein, Unsealing the second end portion of the kit includes: breaking the kit at a break position.

31. The method according to claim 29, wherein, Unsealing the first end portion of the kit includes: piercing a seal.

32. The method according to claim 27, wherein, Unsealing the first end portion of the kit includes: removing a seal from the kit.

33. The method according to claim 27, further comprising: passing an instrument through the inlet / outlet at the first end portion of the kit.

Images